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Eye DiseasesNCT04334499

Mitochondrial DNA in Vitreous Fluid and Blood in Patients With Eye Disease or Ocular Trauma.

An observational study of Eye Diseases and Ophthalmic Trauma, run by The University of Texas Medical Branch, Galveston.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is to characterize mitochondrial DNA (mtDNA) populations in adults with eye injuries and eye diseases. The eye exam is often hindered by the clouding of tissues involved in injury or disease. Read more about this study

Who is it for?
Ages 20 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Eye Diseases, Ophthalmic Trauma, Mitochondrial DNA
What is being tested?
Sample collection from tissue discard
How many people
0 participants
Where
No sites listed yet
Study dates
21 Feb 2020to 7 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Subjects suffering eye disease or ocular trauma and healthy subjects undergoing ocular surgery which may include the discard of vitreous humor.

Who may be able to join

  • a) Target group
  • Age ≥ 20 years old
  • Subjects must not be nursing, pregnant or planning to become pregnant. Subjects of child bearing potential must have a documented negative pregnancy test at the time of preoperative assessment or not be of child bearing potential. Identified eye disease including but not limited to age-related macular degeneration, glaucoma and/or diabetic retinopathy.
  • Scheduled ophthalmic surgery with expected vitreal humor discard.
  • Subject has provided written informed consent to participate in this protocol. b) Control group
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  • Age ≥ 20 years old
  • Subjects must not be nursing, pregnant or planning to become pregnant. Subjects of child bearing potential must have a documented negative pregnancy test at the time of preoperative assessment or not be of child bearing potential.
  • Lack of identified eye disease.
  • Scheduled ophthalmic surgery with expected vitreal humor discard.
  • Subject has provided written informed consent to participate in this protocol.

Who cannot join

  • a) Target group
  • Age < 20 years old
  • Subject is nursing, pregnant, planning to become pregnant or of child bearing potential and does not agree to the use of reliable method of contraception during their participation in the study. A pregnancy test must be administered to women of childbearing potential at the time of preoperative assessment.
  • Identified eye disease including but not limited to age-related macular degeneration, glaucoma and/or diabetic retinopathy.
  • Subject has not completed informed consent to participate in this protocol. b) Scheduled ophthalmic surgery with expected vitreal humor discard Control group
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  • Age < 20 years old
  • Subject is nursing, pregnant, planning to become pregnant or of child bearing potential and does not agree to the use of reliable method of contraception during their participation in the study. A pregnancy test must be administered to women of childbearing potential at the time of preoperative assessment.
  • Lack of identified eye disease.
  • Subject has not completed informed consent to participate in this protocol. Scheduled ophthalmic surgery with expected vitreal humor discard.

About this study

Official title: Investigation of the Relationship Between Mitochondrial DNA in Vitreous Fluid and Blood in Patients With Eye Disease or Ocular Trauma.

This study is to characterize mitochondrial DNA (mtDNA) populations in adults with eye injuries and eye diseases. The eye exam is often hindered by the clouding of tissues involved in injury or disease. This protocol examines the use of mtDNA populations as indicators of developing inflammation and resolution of injury. This may be used to provide proactive treatment or define appropriate treatment needs beyond the indications of an ophthalmological exam.

Read the detailed description

The study aim to test correlation between the presence of the mitochondrial DNA in vitreous fluid and blood in patients that are admitted to UTMB's Eye clinic. The goal of the study is to analyze 4 groups of 30 samples of each major ocular disease and injury: age-related macular degeneration, glaucoma and diabetic retinopathy and ocular trauma. Up to 300 subjects may be consented to this study in order to meet recruitment goals. In this study we will use only otherwise discarded eye's vitreous together with a blood sample that is collected during surgery. Patients with ophthalmic surgery scheduled that may result in discarded vitreal fluid will be identified from the clinic schedule or by physician in the emergency room. The possibility of vitreous collection in a surgery may be uncertain. If a subject does not have discarded vitreous from a given surgery they will be screen failed prior to blood draw or data collection from electronic medical record from that moment forward. Subjects will be approached when appropriate for interest in participation in the study by their clinical faculty surgeon. An informed consent briefing will be provided by the clinical research coordinator with an opportunity to ask questions of both the coordinator, the clinical faculty surgeon and the principle investigator. Copies of the consent will be provided for the patient to take home. Additional opportunity for questions the morning of surgery will be provided. Consent signature will be obtained prior to any medication administration the upon admission for surgery. Samples if available will be collected during the eye surgery. Up to 1ml of vitreous fluid and up to 10 ml of blood will be collected from each patient. Samples will be stored at room temperature and transferred directly to Dr. Szczesny's laboratory. Vitreous fluid will be frozen for further analysis and blood plasma will be processed using histopaque and centrifugation prior freezing. Two types of analysis will be conducted with collected biospecimens.1) Total DNA will be isolated, follow by analysis with real-time quantitative polymerase chain reaction (RTq-PCR) using set of primers to identify the presence of the mitochondrial DNA and nuclear DNA as a control. 2) Extracellular vesicles will be isolated using ultracentrifugation or commercially available kit followed by analysis of the mitochondrial and nuclear DNA and/or plasma membrane markers using RTq-PCR and/or Western blot. Electronic medical records will be accessed to collect demographics and ophthalmologic diagnostic information and information on other comorbidity diagnoses.

These data points will include age in years, gender, race, ethnicity, presence of age related macular degeneration(AMD) (y/n), type and stage of AMD, use of AREDs vitamins, treatments of AMD, Glaucoma(y/n), type and stage of glaucoma, diabetes, blood glucose, diabetic retinopathy (y/n), type and stage of diabetic retinopathy, treatments of diabetic retinopathy and amount of time prior to this planned surgery, hypertension type and stage, renal disease type and stage, smoking history, cancer, cancer type, treatment or surgery, viral diagnoses (HIV, CMV, HCV), blunt eye trauma history, cataract history, lens removal surgery, cause of vitrectomy, concomitant medications and procedures, eye exam observations relevant to inflammatory processes, Optical coherence tomography data. IOP, visual field [VF] data, visual acuity, gonioscopic findings,.

Being tested
Sample collection from tissue discard
Keywords
mitochondrial DNA, opthalmic trauma, age related macular degeneration, glaucoma, inflammation, inflammatory marker, diabetic retinopathy
Medical subject headings
Eye Diseases, Macular Degeneration, Glaucoma, Diabetic Retinopathy, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sample collection from tissue discardOther

    Collection of vitreous humor tissue and venous blood from subjects undergoing ocular surgery that may provide vitreous humor discarded tissue.

Study groups in NCT04334499
Study groupRoleWhat they receive
Age Related Macular DegenerationSubjects with Age Related Macular Degeneration upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Receives: Other: Sample collection from tissue discard
GlaucomaSubjects with Glaucoma upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Receives: Other: Sample collection from tissue discard
Diabetic RetinopathySubjects with Diabetic Retinopathy upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Receives: Other: Sample collection from tissue discard
Ocular TraumaSubjects with Ocular Trauma upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Receives: Other: Sample collection from tissue discard
ControlSubjects with no ocular disease or trauma comorbidities upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue.
Receives: Other: Sample collection from tissue discard

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantitation of mitochondrial DNA in vitreous humor and serum samples

    mtDNA quantitation by RTq-PCR

    Measured: 1 day

Secondary outcomes (1)
  1. Evaluation of mtDNA quantitation versus ocular comorbidities as described in electronic medical record.

    Collection of comorbidity data from electronic medical record and comparison with quantiative analysis of mtDNA.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2020
  2. Study start21 Feb 2020
  3. Primary completion7 Dec 2022
  4. Study completion7 Dec 2022

Why it stopped: The study was never initiated; Principal Investigator determined that it was not feasible to continue with the study at this time.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04334499
Sponsor's protocol ID
19-0291
Status last verified
Mar 2023
First submitted
1 Apr 2020
Last updated
23 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Study records will be kept confidential as required by law. Except when required by law, your identifiers will not be disclosed outside of the University of Texas Medical Branch (UTMB). For records disclosed outside of UTMB, you will be assigned a unique code number. The key to this code will be kept in a password protected encrypted format on a limited access server behind the UTMB firewall. It will be destroyed at the end of data collection for this study. Study samples will also be kept in a de-identified state with the same 4 digit code as the data collection. These samples will be maintained in secured laboratories of the Department of Ophthalmology. The de-identified samples may be maintained past the end of the study for future research without additional consent. Future researchers will have no information on the identity of the subjects.

Questions about this trial

What is this clinical trial studying?

An observational study of Eye Diseases and Ophthalmic Trauma, run by The University of Texas Medical Branch, Galveston.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantitation of mitochondrial DNA in vitreous humor and serum samples (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.

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